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The MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels during cardiovascular surgical procedures.

The MI DeTACH® is comprised of a Detachable Aortic Clamp Head and a Delivery System. The MI DeTACH® Detachable Aortic Cross Clamp Head is available in three sizes: Small, Medium, and Large (55mm, and 85mm enqagement pads respectively) which are packaged and distributed separately. The Delivery System is comprised of a Delivery Device and Quick Release Device. The Delivery Device is used to deliver, clamp, deploy, unclamp, and retrieve the Clamp Head from the target occlusion site.

The MI DeTACH® Detachable Aortic Cross Clamp Head works by applying compression forces to the vessel by the padded device jaws. The top jaw is a pivot jaw allowing for parallel closure of the vessel during clamping. The amount of compression applied to the vessel for occlusion or partial occlusion is determined or adjusted by the means of the Delivery Device lever actuated jaw closure mechanism. The Clamp Head device contains ratchets that provide clamping tactile feedback to the user. A clutch mechanism prevents the user from applying excessive forces to the vessel by disengaging the lever from the device when specific force is obtained. Upon successfully clamping, the device locks and the handle is then detached leaving the clamp in the body throughout the duration of the procedure. The Delivery Device is then used to unclamp and remove the Clamp Head from the body upon procedure completion. In the event the Delivery Device becomes compromised during the course of a procedure, the Quick Release Device can be used to unclamp and remove the Clamp Head from the body.

The provided text is a 510(k) summary for the MI DeTACH® vascular clamp. This document is a regulatory submission to the FDA, demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices.

It is crucial to understand that this document does NOT describe the acceptance criteria for an AI/ML device, nor does it describe a study involving AI/ML performance.

The MI DeTACH® is a physical medical device (a vascular clamp), and the "performance data" section refers to non-clinical testing for safety and functional requirements of this mechanical device, not AI/ML performance.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or ground truth establishment for a training set) because this document does not pertain to an AI/ML device.

The "Performance Data" section (VII) outlines non-clinical testing performed to support the substantial equivalence of the MI DeTACH® to its legally marketed predicate devices. This includes:

• Design Verification and Validation Testing: This confirmed the product meets its requirements through:
  • Vessel Occlusion Testing
  • Clamping Force Distribution Testing
  • Human Factors/Usability Studies
  • Simulated Use Testing
• Sterilization and Shelf Life Testing: Confirmed product safety and effectiveness for both the sterile clamp head and the non-sterile delivery system, including cleaning, sterility, fatigue, and packaging/transport testing.
• Biocompatibility Testing: Conducted in accordance with FDA guidance and ISO 10993-1, including:
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Acute Systemic Toxicity
  • Pyrogen Testing
  • Hemolysis

The document explicitly states that "Animal testing was not required" and "Clinical testing was not required" to demonstrate substantial equivalence.

In summary, the provided text does not contain any information relevant to the AI/ML-related questions you have asked.

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